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Office of Research Compliance and Assurance

Human Subjects

Vulnerable Populations
The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations:
Research Involving Prisoners
Investigator Checklist for Studies Involving Prisoners
Guidelines: Requirements for Research Involving Children
Investigator Checklist for Research Involving Children
Ambulatory Pediatric Association Policy Statement (2/2005)
American Academy of Pediatrics: Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations

Pregnant Women and/or Fetuses:
Investigator Checklist for Research Involving Pregnant Women and Fetuses (10/2006)
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (10/2006)
Decision Impaired Persons
The complete OHRP guidelines can be found at
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